Replagal

RSS

agalsidase alfa

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Replagal. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Replagal.

This EPAR was last updated on 31/01/2018

Authorisation details

Product details
Name
Replagal
Agency product number
EMEA/H/C/000369
Active substance
agalsidase alfa
International non-proprietary name (INN) or common name
agalsidase alfa
Therapeutic area (MeSH)
Fabry Disease
Anatomical therapeutic chemical (ATC) code
A16AB03
OrphanOrphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Publication details
Marketing-authorisation holder
Shire Human Genetic Therapies AB
Revision
21
Date of issue of marketing authorisation valid throughout the European Union
03/08/2001
Contact address
Vasagatan 7
111 20 Stockholm
Sweden

Product information

21/11/2017 Replagal - EMEA/H/C/000369 - IAIN/0096

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Other alimentary tract and metabolism products

Therapeutic indication

Replagal is indicated for long-term enzyme-replacement therapy in patients with a confirmed diagnosis of Fabry disease (α-galactosidase-A deficiency).

Assessment history

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